Clinical Trial to Evaluate the Efficacy and Safety of CKD-386

Dyslipidemia Patients With Hypertension Clinical Trial

Official title:

A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase III Trial to Evaluate the Efficacy and Safety of D013, D326 and D337 Combination Therapy in Dyslipidemia Patients With Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04312698
• Other study ID #: A83_03DL/HT1903
• Status: Completed
• Phase: Phase 3
• Start date: August 29, 2019
• Est. completion date: June 18, 2021

Study information

• Verified date: July 2021
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical Trial to Evaluate the Efficacy and Safety of CKD-386

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 18, 2021
• Est. primary completion date: June 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Subjects are diagnosed with Dyslipidemia Patients with Hypertension or are being administered anti-hypertension and anti-hypertension drugs after diagnosis.

2. Subjects who agreed to participate in this clinical trial voluntarily.

Exclusion Criteria:

1. Subjects who were satisfied specific blood pressure levels that measured at screening period.

2. Subjects who were satisfied specific lipid levels that measured at screening period.

3. Subjects who cannot participate in a clinical trial based on the PI's judgment.

Related Conditions & MeSH terms

• Dyslipidemia Patients With Hypertension
• Dyslipidemias
• Hypertension

Intervention

Drug:
• D013, D326, D337
Experimental: Group 1 Patients assigned to this group are treated with D013, D326, D337
• placebo of D013, D326, D337
Placebo Comparator: Group 1 Patients assigned to this group are treated with D326, D337, placebo of D013
• D013, placebo of D326, placebo of D337
Placebo Comparator: Group 2 Patients assigned to this group are treated with D013, placebo of D326, placebo of D337

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Medical Center Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change rate from baseline in LDL-C	Compare experimental group 1 with comparator group 1	8 weeks after drug administrations
Primary	Change from baseline in MSSBP	Compare experimental group 1 with comparator group 2	8 weeks after drug administrations